Identity
- Trade Name
- Halo Systems FDA UDI
- Generic Name
- Cervical spine immobilization head ring FDA UDI
- Device Name
- RESOLVE HALO COMP TRAY FDA UDI
- Model / Reference
- 540C FDA UDI
- Description
- RESOLVE HALO COMP TRAY FDA UDI
Identifiers
- Catalog Number
- 540C FDA UDI
- Primary DI / UDI-DI
- 05690977165335 FDA UDI
- 510(k) Number
- K051918 FDA UDI
- FDA Product Code
- HAX FDA UDI
- GMDN Term
- Cervical spine immobilization head ring FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5960 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
Halo Systems by Ossur Americas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ossur Americas
Sources (1)
- FDA UDI cbadb6d9-1642-47e1-a369-2fb9a97c5d08 36 fields · synced May 30, 2026